Claims about the health benefits of foods and nutritional supplements have proliferated in recent years, most of them based on studies measuring ingredients' effects on biomarkers as substitutes for actual clinical outcomes.
The use of biomarkers is common in drug, device, and nutritional studies, but the U.S. Food and Drug Administration has been hampered in its ability to evaluate food health claims in part because it lacks a process accepted across the regulatory, food, and medical communities to assess the validity and appropriateness of these biological benchmarks.
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, a new report by the Institute of Medicine, offers a way the agency can consistently and rigorously conduct such assessments.
Advance copies of the report will be available to reporters only beginning at 10 a.m. EDT on Tuesday, May 11. The report is embargoed and not for public release before 11 a.m. EDT on Wednesday, May 12. Reporters can obtain a copy by contacting the National Academies' Office of News and Public Information at tel. 202-334-2138 or e-mail news@nas.edu.